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Effects of Flywheel Exercise on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy (CP-Flywheel)

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ClinicalTrials.gov Identifier: NCT03124628
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Rodrigo Fernandez Gonzalo, Karolinska Institutet

Brief Summary:

The main purpose of this project is to improve physical function and muscle health in teenagers and young adults with cerebral palsy (CP) by using an eccentric-overload resistance exercise model

Specific aims

  1. To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in inducing muscle, functional and gait performance adaptations in teenagers with CP.
  2. To increase force, power and muscle mass in the lower limbs of patients with cerebral palsy.
  3. To improve gross motor function, balance and gait through eccentric-overload resistance exercise in teenagers suffering from cerebral palsy.

We hypothesize that the time-effective flywheel resistance exercise paradigm will result in greater gains in muscle mass and function in teenagers with CP, when compared with conventional weight-stack technology. Importantly, we believe these adaptations will be translated into enhanced gross motor function, balance and gait performance.

Forty teenagers and young adults (age range 16-23 yr) with spastic CP will be recruited. They will be randomly assigned to flywheel (FL; n=20) or weight-stack (WS; n=20) resistance exercise. During 8 weeks, all the teenagers will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients will perform either flywheel (FL group) or conventional (WS group) leg press resistance exercise twice per week. Muscle force, power and activity (electromyography; EMG), leg extension lag, co-contraction, balance, functional mobility, gait quality, and muscle and fat thickness of lower extremities are assessed in all patients before and after the 8-week intervention (Fig. 1).


Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Flywheel resistance exercise Other: Weight-stack resistance exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Flywheel Resistance Exercise Training on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Flywheel resistance exercise
During 8 weeks, all the subjects will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients in this arm will perform flywheel leg press resistance exercise twice per week.
Other: Flywheel resistance exercise
Flywheel resistance exercise, originally designed to maintain function, size and quality of skeletal muscle during spaceflight, employs iso-inertial technology rather than gravity dependent weights, which allows for coupled accommodated concentric and eccentric muscle actions, and brief episodes of eccentric overload.
Other Name: Yo-Yo technology

Active Comparator: Weight-stack resistance exercise
During 8 weeks, all the subjects will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients in this arm will perform conventional, weight-stack leg press resistance exercise twice per week.
Other: Weight-stack resistance exercise
Conventional weight-stack resistance exercise
Other Name: Conventional resistance exercise




Primary Outcome Measures :
  1. Muscle performance [ Time Frame: Change from pre- to post-intervention (8 wks) ]
    Unilateral maximal voluntary isometric force is measured in both legs with force sensors. Similarly, unilateral (both legs) concentric and eccentric peak power is assessed through an encoder system. Furthermore, dynamic force during concentric and eccentric actions is measured via force sensors.

  2. Muscle architecture [ Time Frame: Change from pre- to post-intervention (8 wks) ]
    Vastus lateralis muscle thickness, together with fascicle pennation angle and muscle echogenicity, will be assessed using ultrasound technique in both legs. Thigh circumference will be assessed using measurement tape.

  3. Electromyography of lower limb muscles [ Time Frame: Change from pre- to post-intervention (8 wks) ]
    Muscle activation (mV) will be assessed in lower limb muscles (i.e. vastus lateralis, biceps femoris, gluteus medius, medial gastrocnemius) using surface electromyography techniques

  4. Assessment of activities of daily living [ Time Frame: Change from pre- to post-intervention (8 wks) ]
    Assessment of activities of daily living is measured using the Timed Up-and-Go test, the Chair-stand and the 6-min walking test.

  5. Gait performance adaptations to training including muscle activation and co-contraction during walking [ Time Frame: Change from pre- to post-intervention (8 wks) ]
    Gait performance will be analyzed using an 8-camera 3-D kinematic VICON system and force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital. Overall gait pathology will also be assessed using the multivariate Gait Deviation Index. Muscle activation and co-contraction during gait will be assessed using wireless surface electromyography

  6. Gross motor function [ Time Frame: Change from pre- to post-intervention (8 wks) ]
    Gross motor function will be assessed using Gross Motor Function Measure (GMFM)

  7. Balance [ Time Frame: Change from pre- to post-intervention (8 wks) ]
    Static and dynamic balance is assessed using force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital

  8. Muscle spasticity [ Time Frame: Change from pre- to post-intervention (8 wks) ]
    Spasticity will be assessed using the Ashworth scale


Secondary Outcome Measures :
  1. Subcutaneous fat thickness [ Time Frame: Change from pre- to post-intervention (8 wks) ]
    Subcutaneous fat thickness of the thigh of both legs will be assess using ultrasound techniques



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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Teenagers and young adults between 16-25 years of age
  • Unilateral or bilateral spastic cerebral palsy
  • Gross Motor Function Classification System (GMFCS) of level I, II or III.

Exclusion Criteria

  • Surgical treatments of the knee extensor apparatus within the last 12 months
  • Botulinum toxin treatment within the last six months
  • Ongoing intrathecal baclofen treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124628


Contacts
Contact: Rodrigo Fernandez-Gonzalo, PhD +46706840604 rodrigo.gonzalo@ki.se
Contact: Ferdinand von Walden, MD, PhD ferdinand.vonwalden@ki.se

Locations
Sweden
Karolinska Institutet Recruiting
Stockholm, Sweden, 17177
Contact: Eva Pontén, MD, PhD       eva.ponten@ki.se   
Principal Investigator: Rodrigo Fernandez-Gonzalo, PhD         
Principal Investigator: Ferdinand Von Walden, MD, PhD         
Principal Investigator: Eva Pontén, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Study Director: Eva Pontén, MD, PhD Karolinska Institutet

Responsible Party: Rodrigo Fernandez Gonzalo, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03124628     History of Changes
Other Study ID Numbers: Flywheel CP
16037 ( Other Grant/Funding Number: Promobilia )
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases